Mobile Health Intervention for Young Adult Cancer Survivors

(mHealthAYA Trial)

No longer recruiting at 1 trial location

Overseen By Hannah Arem, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: Significant psychological disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new phone and app-based program designed to help young adult cancer survivors feel more hopeful and improve their quality of life. It consists of two parts: one focuses on general health education, while the other uses an empirically supported protocol with skills and activities to boost hopeful thinking. The trial seeks participants diagnosed with cancer between ages 20-39, who have completed their main cancer treatments within the last three years, and have access to a smartphone. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative approaches that may enhance the well-being of future cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a phone- and app-based intervention to promote hope among young adult cancer survivors.

What prior data suggests that this protocol is safe for young adult cancer survivors?

Research shows that treatments designed for young adult cancer survivors are generally safe. These treatments often include psychological support and behavior change strategies, which participants usually handle well. Studies on similar treatments have not identified major side effects, indicating that serious problems are rare or absent. The main goal is to improve mental health and quality of life, and research has shown these treatments can help. Since this approach uses proven methods like cognitive behavioral therapy and positive psychology, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique mobile health intervention tailored for young adult cancer survivors, focusing on improving quality of life. Unlike traditional approaches that might rely heavily on medications or in-person therapy sessions, this intervention leverages an empirically supported protocol refined with evidence-based strategies. It incorporates elements of cognitive behavioral therapy and positive psychology, delivered through an 8-week curriculum that includes psychoeducation, skill-building, and self-monitoring. This innovative method aims to foster hopeful thinking and improve mental health and health behaviors, offering a potentially more accessible and personalized approach to survivor care.

What evidence suggests that this trial's treatments could be effective for young adult cancer survivors?

This trial compares two approaches for young adult cancer survivors. The intervention arm uses a new mobile health program aimed at increasing hope and improving quality of life. This program incorporates techniques from cognitive behavioral therapy and positive psychology, which have successfully improved mental health and life satisfaction. Although specific data for this program is not yet available, similar programs have helped young survivors manage symptoms and navigate life after cancer. The focus on encouraging hopeful thinking is new and could lead to better mental health and healthier habits over time. Meanwhile, the attention control arm provides health education based on American Cancer Society and NCI guidelines, focusing on maintaining a healthy weight, physical activity, and nutrition. ^{1 2 5 6 7}

Who Is on the Research Team?

Carla J Berg, PhD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

This trial is for young adults aged 20-39 who have been treated for stages I-IV cancer within the last three years. Participants should not have significant psychological disabilities, must understand English, and need to have a smartphone. They also must be willing to commit to an 8-week study that's delivered remotely.

Inclusion Criteria

No significant psychological disabilities

Able to complete forms and understand instructions in English

Smartphone access

Exclusion Criteria

Significant psychological disabilities

I finished my cancer treatment over three years ago or am currently in treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week phone- and app-based intervention to promote hope and mitigate life disruption caused by cancer diagnosis and treatment

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of hope, quality of life, and health behaviors

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Empirically Supported Protocol
• Health Education

Trial Overview The trial is testing an 8-week phone and app-based intervention designed to boost hope and improve quality of life after cancer treatment. It involves comparing this new method with a control group in a randomized controlled trial among 150 young adult survivors.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.

Group II: Attention Control Active Control 1 Intervention

Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10719817/

Sleep Treatment Education Program for Young Adult Cancer ... Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after completing treatment. In addition to potential health ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225001148

Long-term surveillance recommendations for young adult ... Advancements in cancer treatment have led to increased survival rates among young adult cancer survivors (YACS). However, these individuals face unique ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9438455/

Cancer survivorship care for young adults: a risk-stratified ... Young adult (YA) cancer survivors have high rates of adverse health and psychosocial outcomes. This risk-stratified, multicenter, randomized controlled trial ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05905250

NCT05905250 | mHealth for Young Adult Cancer Survivors The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors.

5. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01510-7

Improving symptom management for survivors of young adult ... Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial.

6. researchprotocols.org researchprotocols.org/2024/1/e60762/PDF

Sleep Treatment Education Program for Cancer Survivors Background: Cancer survivors are at increased risk for chronic insomnia, even years after treatment completion. As insomnia.

7. mdpi.com mdpi.com/2072-6694/13/10/2460

Online, Group-Based Psychological Support for Adolescent ... Recapture Life participants also reported higher negative impact of cancer, anxiety and depression at a 12-month follow-up. Additional analyses suggested that ...